Heart Failure With Reduced Ejection FractionENIGMA-HFNCT05806970
Email Nudges to Improve GDMT (MRA) Adherence in Heart Failure
A study testing Email Nudge in people with Heart Failure With Reduced Ejection Fraction, run by University of California, Los Angeles at 1 site in United States.
Trial summary
The Email Nudges to Improve GDMT (MRA) Adherence in Heart Failure (ENIGMA-HF) study is a pragmatic parallel-arm randomized control trial of a quality improvement (QI) intervention involving email nudges to cardiology clinic managers to schedule appointments specific to guideline directed medical therapy (GDMT)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction
- What is being tested?
- Email Nudge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2023to Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Facility: UCLA Health System
- Patient is 18 years of age or older
- Patient is under the care of a UCLA cardiologist
- Patient has a primary diagnosis of HFrEF
- Patient is not currently prescribed an MRA
Who cannot join
- Hyperkalemia
- Chronic kidney disease stage 4 or higher
- Pregnant or breastfeeding patients
- Heart transplant or ventricular-assist device patients
- Hospice patients
- Patients without an LVEF on file
- Patients with an EF >35%
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Los Angeles
Los Angeles, California, 90095
About this study
The Email Nudges to Improve GDMT (MRA) Adherence in Heart Failure (ENIGMA-HF) study is a pragmatic parallel-arm randomized control trial of a quality improvement (QI) intervention involving email nudges to cardiology clinic managers to schedule appointments specific to guideline directed medical therapy (GDMT) initiation, with the goal of optimizing mineralocorticoid-receptor antagonist (MRA) use by patients with heart failure with reduced ejection fraction (HFrEF) cared for by cardiologists within the University of California, Los Angeles (UCLA) Health System.
Read the detailed description
Importance: Guideline directed medical therapy (GDMT) is a specific set of 4 medications proven to improve morbidity and mortality for patients with heart failure (HF) with reduced ejection fraction (HFrEF), yet they are underutilized nationally and internationally. Various quality improvement (QI) interventions have had varying degrees of success at increasing GDMT prescription and titration.
Objective: The purpose of the study is to assess whether email nudges to UCLA Health cardiology clinic managers to schedule GDMT-specific appointments can lead to increased utilization of a specific medication within GDMT called a mineralocorticoid-receptor antagonist (MRA). Pertinent secondary objectives will include evaluating whether email nudges specific to MRA would increase utilization of the other medications in GDMT and whether they would increase appointments specific to GDMT.
Design, Setting, and Participants: The basic design is a pragmatic parallel-arm randomized control trial of a QI intervention. The setting is cardiology outpatient clinics at a large university-based single integrated healthcare system (UCLA Health). Participants are outpatients with HFrEF under the care of a UCLA cardiologist, with an ejection fraction on file, and currently not prescribed an MRA.
Hypothesis: The investigators hypothesize that the intervention will lead to an increased utilization of MRA, compared to the control arm.
- Being tested
- Email Nudge
- Keywords
- Ambulatory Care, Learning Health System, Quality Improvement [QI], Implementation Science, Clinical Decision Support, Mineralocorticoid Receptor Antagonist [MRA], Guideline Directed Medical Therapy [GDMT]
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Email NudgeOther
An email to UCLA Health Cardiology clinic managers with a list of MRA-eligible HFrEF patients and a request to schedule or change cardiology appointments.
| Study group | Role | What they receive |
|---|---|---|
| Intervention - Email Nudge | Experimental | The intervention will include contacting UCLA Health Cardiology clinic managers with a list of all HFrEF patients eligible for an MRA who are cared for by a provider randomized to the intervention arm. Clinic managers will be asked to make an appointment in the next 60 days for these patients with the specific indication: GDMT initiation - consider MRA. If an appointment is already present in the next 60 days, the indication will be changed to: GDMT initiation - consider MRA. Receives: Other: Email Nudge |
| No Intervention - Control Group | No intervention | Providers randomized to the control arm will perform clinical duties as usual. Their patients will receive routine clinical care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of eligible patients prescribed MRA
Proportion of patients that receive an active prescription for mineralocorticoid receptor antagonist (MRA) compared between arms at the end of the study.
Measured: 60 days
Secondary outcomes (5)
Percentage of eligible patients prescribed ACE/ARB/ARNI, beta blocker, or SGLT2i
Proportion of patients that receive an active prescription for angiotensin-converting enzyme inhibitor (ACE), angiotensin II receptor blocker (ARB), angiotensin receptor neprilysin inhibitor (ARNI), beta blocker, or sodium-glucose cotransporter-2 inhibitor (SGLT2i) compared between arms at the end of the study.
Measured: 60 days
Percentage of eligible patients prescribed ACE/ARB/ARNI
Proportion of patients that receive an active prescription for angiotensin-converting enzyme inhibitor (ACE), angiotensin II receptor blocker (ARB), or angiotensin receptor neprilysin inhibitor (ARNI) compared between arms at the end of the study.
Measured: 60 days
Percentage of eligible patients prescribed ARNI
Proportion of patients that receive an active prescription for angiotensin receptor neprilysin inhibitor (ARNI) compared between arms at the end of the study.
Measured: 60 days
Percentage of eligible patients prescribed beta blocker
Proportion of patients that receive an active prescription for beta-blocker compared between arms at the end of the study.
Measured: 60 days
Percentage of eligible patients prescribed SGLT2i
Proportion of patients that receive an active prescription for sodium-glucose cotransporter-2 inhibitor (SGLT2i) compared between arms at the end of the study.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study startApr 2023 (estimated)
- Primary completionJul 2023 (estimated)
- Study completionJul 2023 (estimated)
Why it stopped: Converted clinical trial approach to a quality improvement approach
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Failure With Reduced Ejection FractionStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicholas K. Brownell, MD, University of California, Los Angeles
- Investigators
- Nicholas K Brownell, MD, Principal investigator, University of California, Los AngelesDavid J Cho, MD MBA, Principal investigator, University of California, Los AngelesPooya I Bokhoor, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05806970
- Sponsor's protocol ID
- UCLA IRB#23-000305
- Acronym
- ENIGMA-HF
- Status last verified
- Apr 2024
- First submitted
- 28 Mar 2023
- Last updated
- 1 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brownell NK, Ziaeian B, Fonarow GC. The Gap to Fill: Rationale for Rapid Initiation and Optimal Titration of Comprehensive Disease-modifying Medical Therapy for Heart Failure with Reduced Ejection Fraction. Card Fail Rev. 2021 Nov 26;7:e18. doi: 10.15420/cfr.2021.18. eCollection 2021 Mar.
PubMed 34950508
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Email Nudges to Improve GDMT (MRA) Adherence in Heart Failure
- ClinicalTrials.gov ID
- NCT05806970
- Acronym / sponsor ID
- ENIGMA-HF / UCLA IRB#23-000305
- Keywords
- Ambulatory Care, Learning Health System, Quality Improvement [QI], Implementation Science, Clinical Decision Support, Mineralocorticoid Receptor Antagonist [MRA], Guideline Directed Medical Therapy [GDMT]
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Converted clinical trial approach to a quality improvement approach
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Apr 2023 (estimated)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 10 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Email Nudges to Improve GDMT (MRA) Adherence in Heart Failure (ENIGMA-HF) study is a pragmatic parallel-arm randomized control trial of a quality improvement (QI) intervention involving email nudges to cardiology clinic managers to schedule appointments specific to guideline directed medical therapy (GDMT) initiation, with the goal of optimizing mineralocorticoid-receptor antagonist (MRA) use by patients with heart failure with reduced ejection fraction (HFrEF) cared for by cardiologists within the University of California, Los Angeles (UCLA) Health System.
Detailed description
Importance: Guideline directed medical therapy (GDMT) is a specific set of 4 medications proven to improve morbidity and mortality for patients with heart failure (HF) with reduced ejection fraction (HFrEF), yet they are underutilized nationally and internationally. Various quality improvement (QI) interventions have had varying degrees of success at increasing GDMT prescription and titration.
Objective: The purpose of the study is to assess whether email nudges to UCLA Health cardiology clinic managers to schedule GDMT-specific appointments can lead to increased utilization of a specific medication within GDMT called a mineralocorticoid-receptor antagonist (MRA). Pertinent secondary objectives will include evaluating whether email nudges specific to MRA would increase utilization of the other medications in GDMT and whether they would increase appointments specific to GDMT.
Design, Setting, and Participants: The basic design is a pragmatic parallel-arm randomized control trial of a QI intervention. The setting is cardiology outpatient clinics at a large university-based single integrated healthcare system (UCLA Health). Participants are outpatients with HFrEF under the care of a UCLA cardiologist, with an ejection fraction on file, and currently not prescribed an MRA.
Hypothesis: The investigators hypothesize that the intervention will lead to an increased utilization of MRA, compared to the control arm.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention - Email Nudge | Experimental | Other: Email NudgeThe intervention will include contacting UCLA Health Cardiology clinic managers with a list of all HFrEF patients eligible for an MRA who are cared for by a provider randomized to the intervention arm. Clinic managers will be asked to make an appointment in the next 60 days for these patients with the specific indication: GDMT initiation - consider MRA. If an appointment is already present in the next 60 days, the indication will be changed to: GDMT initiation - consider MRA. |
| No Intervention - Control Group | No intervention | –Providers randomized to the control arm will perform clinical duties as usual. Their patients will receive routine clinical care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Facility: UCLA Health System
- Patient is 18 years of age or older
- Patient is under the care of a UCLA cardiologist
- Patient has a primary diagnosis of HFrEF
- Patient is not currently prescribed an MRA
Key exclusion criteria (7 listed)
- Hyperkalemia
- Chronic kidney disease stage 4 or higher
- Pregnant or breastfeeding patients
- Heart transplant or ventricular-assist device patients
- Hospice patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Email NudgeAn email to UCLA Health Cardiology clinic managers with a list of MRA-eligible HFrEF patients and a request to schedule or change cardiology appointments. | Other | Intervention - Email Nudge |
Primary outcome
Percentage of eligible patients prescribed MRA
Time frame: 60 days
Proportion of patients that receive an active prescription for mineralocorticoid receptor antagonist (MRA) compared between arms at the end of the study.
5 secondary outcomes
Percentage of eligible patients prescribed ACE/ARB/ARNI, beta blocker, or SGLT2i
Time frame: 60 days
Percentage of eligible patients prescribed ACE/ARB/ARNI
Time frame: 60 days
Percentage of eligible patients prescribed ARNI
Time frame: 60 days
Percentage of eligible patients prescribed beta blocker
Time frame: 60 days
Percentage of eligible patients prescribed SGLT2i
Time frame: 60 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- Background: PubMed 34950508Brownell NK, Ziaeian B, Fonarow GC. The Gap to Fill: Rationale for Rapid Initiation and Optimal Titration of Comprehensive Disease-modifying Medical Therapy for Heart Failure with Reduced Ejection Fraction. Card Fail Rev. 2021 Nov 26;7:e18. doi: 10.15420/cfr.2021.18. eCollection 2021 Mar.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas K Brownell, MD principal investigator
University of California, Los Angeles
David J Cho, MD MBA principal investigator
University of California, Los Angeles
Pooya I Bokhoor, MD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Email Nudge in people with Heart Failure With Reduced Ejection Fraction, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of eligible patients prescribed MRA (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05806970, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2024.